Scars After Central Venous Catheters

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Brief Summary:

Most children with cancer need a central venous catheter. These catheters are typically placed on the anterior thorax, where the risk of hypertrophic scarring and keloid development is greatly enhanced. A significant part of the children who have survived childhood cancer are troubled by their scars.

Topical glucocorticoid treatment is known to induce a reduction of the collagen in the connective tissue.

The investigators hypothesize that treatment with topical glucocorticoids for one week before and three weeks after removal of a central venous catheter, will reduce the formation of hypertrophic scarring and keloid development in children.

Condition or disease	Intervention/treatment	Phase
Hypertrophic Scars; Keloids	Drug: Betamethason-17-valerate and fusidic acid; Drug: Fusidic Acid	Phase 3

Study Design

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	60 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:	Prevention
Official Title:	Topical Treatment With Glucocorticoids to Prevent Hypertrophic Scars and Keloid Due to Central Venous Access in Children
Study Start Date :	March 2010
Estimated Primary Completion Date :	August 2014
Estimated Study Completion Date :	July 2016

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
Experimental: Fucicort	Drug: Betamethason-17-valerate and fusidic acid; 0.4 cm creme is applied and covered with a plaster (treatment under occlusion). Dosage every second or third day Treatment is started one week before removal of the central venous catheter and continued for four weeks
Placebo Comparator: Fucidin	Drug: Fusidic Acid; 0.4 cm creme is applied and covered with a plaster (treatment under occlusion). Dosage every second or third day Treatment is started one week before removal of the central venous catheter and continued for four weeks

Outcome Measures

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

1. scars measured by the Vancouver Scar Scale twelve months after central venous catheter removal [ Time Frame: Twelve months ]

Secondary Outcome Measures :

1. Judgement of the scar by Patient and observer scar scale after six months [ Time Frame: six months ]
2. Judgement of the scar by Patient and observer scar scale after twelve months [ Time Frame: twelve months ]
3. scars measured by the Vancouver Scar Scale six months after central venous catheter removal [ Time Frame: six months ]

Eligibility Criteria

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Ages Eligible for Study:	up to 21 Years (Child, Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

• All children and adolescents who have a central venous catheter removed at the Childrens Department of Oncology at Aarhus University Hospital Skejby in the period from March 2010 to July 2011

Exclusion Criteria:

• Known allergy towards plaster or fusidic acid

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

Denmark
Arhus University Hospital Skejby
Aarhus, Aarhus N, Denmark, 8200

Sponsors and Collaborators

Mette Møller Handrup

Investigators

Principal Investigator:	Henrik Hasle, Professor	Aarhus University Hospital Skejby

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications:

Wolfram D, Tzankov A, Pülzl P, Piza-Katzer H. Hypertrophic scars and keloids--a review of their pathophysiology, risk factors, and therapeutic management. Dermatol Surg. 2009 Feb;35(2):171-81. doi: 10.1111/j.1524-4725.2008.34406.x. Review.

Robles DT, Berg D. Abnormal wound healing: keloids. Clin Dermatol. 2007 Jan-Feb;25(1):26-32. Review.

Calaminus G, Weinspach S, Teske C, Göbel U. Quality of survival in children and adolescents after treatment for childhood cancer: the influence of reported late effects on health related quality of life. Klin Padiatr. 2007 May-Jun;219(3):152-7.

Sullivan T, Smith J, Kermode J, McIver E, Courtemanche DJ. Rating the burn scar. J Burn Care Rehabil. 1990 May-Jun;11(3):256-60.

Draaijers LJ, Tempelman FR, Botman YA, Tuinebreijer WE, Middelkoop E, Kreis RW, van Zuijlen PP. The patient and observer scar assessment scale: a reliable and feasible tool for scar evaluation. Plast Reconstr Surg. 2004 Jun;113(7):1960-5; discussion 1966-7.

Hopwood P, Fletcher I, Lee A, Al Ghazal S. A body image scale for use with cancer patients. Eur J Cancer. 2001 Jan;37(2):189-97.

Responsible Party:	Mette Møller Handrup, MD, PhD, Aarhus University Hospital
ClinicalTrials.gov Identifier:	NCT01113125 History of Changes
Other Study ID Numbers:	2009-015163-14; 2009-015163-14 ( EudraCT Number ); 73191198 ( Other Identifier: Danish Medicines Agency ); 20090206 ( Other Identifier: The Danish National Committee on Biomedical Research Ethics )
First Posted:	April 29, 2010
Last Update Posted:	February 12, 2014
Last Verified:	February 2014

Keywords provided by Mette Møller Handrup, Aarhus University Hospital:

hypertrophic scar; keloid; central venous catheter; children; cancer

Additional relevant MeSH terms:

Hypertrophy; Keloid; Cicatrix, Hypertrophic; Pathological Conditions, Anatomical; Collagen Diseases; Connective Tissue Diseases; Cicatrix; Fibrosis	Pathologic Processes; Fusidic Acid; Anti-Bacterial Agents; Anti-Infective Agents; Protein Synthesis Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action